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NCT Number: NCT06836843

Evaluation of Maternal and Neonatal Outcomes in Women Are Conceived Through Assisted Reproductive Technology Compared to Other Fertility Treatments and Naturally Conceived Women: It is a Retrospective Cohort Study Conducted Over a 5-year Period at a Fertility Center in a Lebanese Hospital

Background: The number of couples experiencing difficulties conceiving and seeking treatment for infertility has increased dramatically over time. Treatment options for infertility have evolved significantly over the past four decades, expanding to include assisted reproductive technologies (ART). However, the impact of ART on pregnancy outcomes remains unclear. Studies have shown that ART pregnancies are associated with a higher risk of maternal and neonatal adverse outcomes compared to those resulting from spontaneous conception. To this date, no comprehensive studies have been conducted in Lebanon to assess this association. Therefore, it is crucial to evaluate whether Lebanese women who conceive via ART are at higher risk for maternal and birth-related complications.

Objective: The aim of this study is to evaluate maternal and neonatal outcomes among women who conceived through assisted reproductive technology (ART), compared to those who conceived via other fertility treatments or naturally, at Dr. Ghazeeri's clinic at the American University of Beirut Medical Center.

Methods: Investigators propose to conduct an observational retrospective cohort study involving all pregnant women treated by Dr. Ghazeeri who delivered at the American University of Beirut Medical Center between 2018 and 2023. Pregnancies exposed to assisted reproductive technology (ART) or other fertility treatments will be matched to a group of spontaneous pregnancies based on propensity scores. The study has been initiated following approval from the Institutional Review Board (IRB) at the American University of Beirut Medical Center. Data analysis will be performed using SPSS version 26.

Expected Results: If no associations are found between ART or other fertility treatments and an increased risk of maternal and neonatal outcomes, the results will provide reassurance for mothers seeking these treatments. However, if associations are identified, policymakers will need to establish comprehensive regulations outlining the appropriate use of these technologies. Additionally, these findings would lay the groundwork for obstetricians to implement closer monitoring and more careful management during pregnancy.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Preterm Birth Cardiovascular Diseases Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Mellitus (GDM) Gestational Hypertension Glucose Metabolism Disorders Hypertension Hypertension, Pregnancy-Induced Metabolic Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases Vascular Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Lebanese University

Beirut, Hadath, Lebanon

About this study

i. Study Design Investigators propose to conduct an observational retrospective cohort study on all pregnant women who delivered at Dr. Gahzeeri's clinic at the American University of Beirut Medical Center between 2018 and 2023. Investigators have obtained approval from the Institutional Review Board (IRB) at AUB, which is valid until August 2025.

ii. Sample Size: As this is a retrospective cohort study, the sample size will be determined by the number of participants who meet the inclusion criteria.

iii. Population The patient characteristics will be extracted from the Epic electronic health record system at the hospital. Pregnancies exposed to ART or other fertility treatments will be matched to spontaneous pregnancies based on propensity scores

In this study, the subjects will be divided into two groups:

  • Exposed group:
  • Group One (ART group): pregnancies conceived via either IVF/ICSI and/or Assisted hatching (AH) and/or Pre-implantation genetic testing (PGT).
  • Group one will also be subdivided into fresh embryo transfer (ET) and frozen embryo transfer (FET) subgroups based on the type of embryo transfer method used.
  • Group Two (Non-ART group): pregnancies conceived through ovulation induction (OI) and/or intrauterine insemination (IUI) and/or corrective gynecological surgery.
  • Non-exposed group: spontaneous pregnancies, defined as pregnancies resulting from natural conception.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All pregnant ladies of Lebanese Nationality only who delivered at the American University of Beirut Medical Center (AUB-MC) between Nov 2018- Nov 2023
  • Pregnancies that were delivered at least 20 weeks of gestation (≥ 20 weeks)
  • All pregnant women who are in procreation age (20-50 years old)
  • For pregnant women by ART: only if ART is done at the AUB-MC
  • Subject's file being accessible for all the three trimesters
  • Subjects being followed up until delivery only at the AUB-MC
  • Subjects whom their baby or babies' records are available (it could be multiples)

Exclusion criteria

  • Subjects who started their follow-up after the 1st trimester (missing data before 12 weeks).
  • All subjects with history of severe chronic conditions before gestation such as, pre-existing cancer, heart diseases (coronary artery disease, arrhythmia, cardiac defects, ischemic stroke, venous thromboembolism, liver disease and/or kidney disease, history of nervous system disorders (seizures, depression).
  • Subjects who undergone ART elsewhere
  • Subjects who lost to follow up during their pregnancies (missing data)
  • Moms who delivered outside the AUBMC hospital

Treatment and study plan

Since this is an observational study rather than an interventional study, the exposure type refers to all potential factors influencing pregnancy both before and during pregnancy

Other

Since this is an observational study rather than an interventional study or clinical trial, the exposure type refers to all potential factors influencing pregnancy both before conception and during pregnancy. These exposures include:

Lifestyle habits: Such as obesity, smoking and alcohol use before and during pregnancy.

Sociodemographic factors: Such as age, residence, medical insurance. Medications: Any prescription, over-the-counter, or herbal medications used before or during pregnancy.

Past medical history: Pre-existing medical conditions or illnesses, such as hypertension, diabetes, or autoimmune diseases, that could affect pregnancy.

Past surgical history: Previous surgeries, especially those related to the reproductive system or any that may impact pregnancy outcomes.

Previous pregnancies: Information about past pregnancies, including the number of full-term and preterm births, complications, and outcomes.

Abortions: Any history of miscarriages

Primary outcomes

  1. Percentage of Pregnant Women with Gestational Diabetes Mellitus (GDM) in the Exposed Group versus Non-Exposed Group

    Time frame: 24-28 weeks of gestation

    GDM will be diagnosed using standardized glucose screening tests; Oral Glucose Tolerance Test (OGTT) between 24 and 28 weeks of gestation.

    One-hour OGTT (after drinking a 50g glucose solution):

    Different cut-off thresholds are used for the 50-g glucose tolerance screening to be considered an abnormal result, including ≥130 mg/dL , ≥135 mg/dL, and ≥140 mg/dL.

    • Possible Gestational Diabetes (possible diagnosis if ≥140 mg/dL); and here the patient requires a confirmatory diagnosis which is the three-hours OGTT (after drinking 100g glucose solution):
    • Normal <140 mg/dL
    • Gestational Diabetes ≥140 mg/dL

  2. Percentage of Pregnant Women with Gestational Hypertension in the Exposed Group versus the Non-Exposed Group

    Time frame: from 20 weeks + 1 day to 40 weeks of gestation

    Gestational hypertension is confirmed when blood pressure greater than or equal to 140mmHg systolic or 90mmHg diastolic on 2 separate occasions at least 4 hours apart after 20 weeks of pregnancy when previous blood pressure was normal

  3. Percentage of Babies Born Preterm to Women in the Exposed Group versus Non-Exposed Group

    Time frame: Before 37 weeks of gestation

    Preterm is defined as babies born alive before 37 weeks of pregnancy are completed.

  4. Percentage of Babies Born Small for Gestational Age to Women in the Exposed Group versus Non-Exposed Group

    Time frame: day one of birth

    Infants with a birth weight below the 10th percentile for their gestational age.

  5. Percentage of Babies Born Large for Gestational Age to Women in the Exposed Group versus Non-Exposed Group

    Time frame: day one of birth

    Infants with a birth weight above the 90th percentile for their gestational age

Secondary outcomes

  1. Percentage of Pregnant Women with Polyhydramnios in the Exposed Group versus Non-Exposed Group

    Time frame: During 40 weeks of gestation

    Polyhydramnios is usually defined as an amniotic fluid index (AFI) of more than 24 cm or a single pocket of fluid at least 8 cm in depth that results in an amniotic fluid volume of more than 2000 ml.

  2. Percentage of Pregnant Women with Oligohydramnios in the Exposed Group versus Non-Exposed Group

    Time frame: During 40 weeks of gestation

    It is defined as an amniotic fluid index (AFI) less than 7 cm or the absence of a fluid pocket 2-3 cm in depth

Other outcomes

  1. Percentage of Pregnant Women with Hypothyroidism in the Exposed Group versus Non-Exposed Group

    Time frame: During 40 weeks of gestation

    The diagnosis of hypothyroidism is made from the TSH value > 4.0 mIU/L.

  2. Percentage of Pregnant Women with Hyperthyroidism in the Exposed Group versus Non-Exposed Group

    Time frame: During 40 weeks of gestation

    The diagnosis of hyperthyroidism is made from the TSH value <0.1 mUI/L

Sponsors and collaborators

Lead sponsor

Lebanese University

Other

Collaborators

  • American University of Beirut Medical Center

Registry information

Official study title

Evaluation of Maternal and Neonatal Outcomes Among Lebanese Women Conceived Through Assisted Reproductive Technology

Acronym: non

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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